ev3, Protg Rx Tapered Carotid Stent System, SEPX-8-6-40-135, Sterile EO, Rx only. Indicated for the treatment of patient

FDA device recall Z-0879-2015 · posted 2014-12-29 · Terminated

Recall details

Recalling firm

Ev3, Inc.

Reason for recall

Two production lots of the Protege Rx Tapered Carotid Stent Systems (SECX-10-7-40-135, Lot # 9922452 & SEPX-8-6-40-135, Lot # 9922795) because of a product labeling error.

Action taken

Consignees were sent on 12/4/2014 a Covidien "Urgent Field Safety Notice" letter dated 4th December 2014. The letter described the problem and the product involved in the recall. Advised consignees to quarantine, discontinue use of the device and return the product to Covidien. They also requested consignees to complete the "Recall Verification Form" and return it to Covidien. For questions, customers can contact their local Covidien Representative.

Root cause

Packaging process control

Status

Terminated

Product code

NIM

Quantity affected

24

Distribution

International Only Distribution -- RUSSIA, ROMANIA, UNITED KINGDOM, GERMANY, ITALY, SPAIN, FRANCE, TURKEY, POLAND, and JAPAN.

Date initiated

2014-12-04

Date posted

2014-12-29

Date terminated

2015-07-17

Location

Plymouth, MN